Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

Phase 2CompletedNCT00950989

Amgen252 enrolled

Overview

Study in participants with RA who have an inadequate response to methotrexate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

252

Conditions

Rheumatoid Arthritis

Interventions

BrodalumabDRUG

3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10

PlaceboDRUG

3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10

MethotrexateDRUG

Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Active RA for least 6 months * Current RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and at least 1 of the following at screening: Erythrocyte sedimentation rate ≥ 28 mm or C-reactive protein \> 15 mg/L * At least 1 of the following at screening: Rheumatoid factor positive or Anti-cyclic citrullinated peptide antibody positive * Currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1. Exclusion Criteria: * Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening * Class IV RA * Felty's syndrome * Presence of serious infection * Significant concurrent medical conditions * Pregnant or breast feeding * Significant Laboratory abnormalities * Any disease-modifying anti-rheumatic drug (DMARD) other than methotrexate within 28 days * Leflunomide or live vaccines within 3 months * Previous use of any experimental or commercially available biologic DMARD

Outcomes

Primary Outcomes

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: * 50% improvement in 68 tender joint count; * 50% improvement in 66 swollen joint count; and * 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.

Time frame: Baseline, week 12

Secondary Outcomes

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * 20% improvement in 68 tender joint count; * 20% improvement in 66 swollen joint count; and * 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.

Time frame: Baseline, Week 12

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12

A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: * 70% improvement in 68 tender joint count; * 70% improvement in 66 swollen joint count; and * 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.

Data from ClinicalTrials.gov

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